Mabwell, an innovation-focused biopharmaceutical company with an integrated end-to-end pharmaceutical value chain, announced that its wholly owned subsidiary, T-mab, has successfully completed the Brazilian Health Regulatory Agency (ANVISA) GMP on-site inspection for its denosumab biosimilar candidates, 9MW0311, a biosimilar of Prolia®, and 9MW0321, a biosimilar of Xgeva®. This marks Mabwell’s second GMP certification from a regulatory authority belonging to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), following its earlier certification in Jordan.
Brazil, a BRICS member and the largest economy in Latin America, also has the region’s largest pharmaceutical market. As a PIC/S member, ANVISA maintains stringent GMP requirements that are aligned with international standards established by the International Council for Harmonisation (ICH) and the World Health Organization (WHO). Successfully completing the inspection demonstrates the strength of Mabwell’s quality management and manufacturing systems and could support the company’s efforts to expand into other PIC/S-regulated markets.
Mabwell has previously filed marketing authorization applications for its denosumab biosimilars in eight countries, including Brazil. The company has also secured marketing approval for the products in Pakistan.
Brazil, a BRICS member and the largest economy in Latin America, also has the region’s largest pharmaceutical market. As a PIC/S member, ANVISA maintains stringent GMP requirements that are aligned with international standards established by the International Council for Harmonisation (ICH) and the World Health Organization (WHO). Successfully completing the inspection demonstrates the strength of Mabwell’s quality management and manufacturing systems and could support the company’s efforts to expand into other PIC/S-regulated markets.
Mabwell has previously filed marketing authorization applications for its denosumab biosimilars in eight countries, including Brazil. The company has also secured marketing approval for the products in Pakistan.